G/SPS/N/USA/3056/Add.1  
 
25 April 2022  
(22-3236) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
Addendum  
The following communication, received on 21 April 2022, is being circulated at the request of the 
Delegation of  the United States of America . 
 
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Beverages: Bottled Water, Final Rule  
The Food and Drug Administration (FDA or we) is revising the quality standard for bottled water to 
specify that bottled water to which fluoride is added by the manufacturer may not contain fluoride in 
excess of 0.7 milligrams per liter (mg/L), which available data sugg ests provides an optimal balance 
between the prevention of dental caries and the risk of dental fluorosis. This final rule revises the 
current allowable levels, which range from 0.8 to 1.7 mg/L, for fluoride in domestically packaged and 
imported bottled wa ter to which fluoride is added. We are taking this action to make the quality 
standard regulation for fluoride added to bottled water consistent with the 2015 recommendation by 
the US Public Health Service (PHS) for community water systems that add fluorid e for the prevention 
of dental caries. This action will not affect the allowable levels for fluoride in bottled water to which 
fluoride is not added by the manufacturer (such bottled water may contain fluoride from its source 
water).  
This rule is effective  21 June 2022. The compliance date is 17 October 2022.  
https://www.govinfo.gov/content/pkg/FR -2022-04-20/pdf/2022 -08273.pdf  
https://members.wto.org/crnattachments/2022/SPS/USA/22_2974_00_e.pdf  
This addendum concerns a:  
[ ] Modification of final date for comments  
[X] Notification of adoption, publication or entry into force of regulation  
[ ] Modification of content and/or scope of previously notified draft regulation  
[ ] Withdrawal of proposed regulation  
[ ] Change in proposed date of adoption, publication or date of entry into force  
[ ] Other:  
Comment period: (If the addendum extends the scope of the previously notified measure 
in terms of products and/or potentially affected Members, a new deadline for receipt of 
comments should be provided, normally of at least 60 calendar days. Under other 
circumstances, such as extension of originally announced final date for comments, the 
comment period provided in the addendum may vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) : Not applicable  G/SPS/N/USA/3056/Add.1  
 
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  Agenc y or authority designated to handle comments: [  ] National Notification Authority, 
[ ] National Enquiry Point. Address, fax number and e -mail address (if available) of other 
body:  
For access to the docket to read background documents or comments received, go to 
https://www.regulations.gov  and insert the docket number found in brackets in the heading of this 
final rule into the "Search" box  and follow the prompts, and/or go to the Dockets Management Staff, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, +(240) 402 7500.  
 
FOR FURTHER INFORMATION CONTACT: David Whitman, Center for Food Safety and Applied Nutrition 
(HFS–820), Food and Drug Ad ministration, 5001 Campus Dr., College Park, MD 20740, +(240) 402 
3754, David.Whitman@fda.hhs.gov ; or Deirdre Jurand, Center for Food Safety and Applied Nutrition, 
Office of Regulations and Policy (HFS –024),  Food and Drug Administration, 5001 Campus Dr., 
College  Park, MD 20740, +(240) 402 2378.  
Text(s) available from: []  National Notification Authority, [  ] National Enquiry Point. 
Address, fax number and e -mail address (if available) of other body:  
Text can  be found in the Federal Register, Vol. 87, No. 76, page 23434 or on the internet at: 
https://www.govinfo.gov/content/pkg/FR -2022-04-20/pdf/2022 -08273.pdf . 
 
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